1

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

U.S. DEPARTMENT OF AGRICULTURE

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

+ + + + +

BIOTECHNOLOGY REGULATORY SERVICES

+ + + + +

STAKEHOLDER MEETING

+ + + + +

WEDNESDAY

DECEMBER 9, 2020

+ + + + +

The stakeholder meeting convened via 

Teleconference, at 1:00 p.m. EST, Doug McKalip, 

BRS Senior Policy Advisor, presiding.

PRESENT

DOUG McKALIP, BRS Senior Policy Advisor

IBRAHIM SHAQIR, BRS Associate Deputy 

Administrator

BERNADETTE JUAREZ, BRS Deputy Administrator

ALAN PEARSON, BRS Associate Deputy Administrator

DOUG GRANT, Director, BRS Regulatory Operations 

Program
2

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

C-O-N-T-E-N-T-S

Welcome 3

Doug McKalip

New BRS Staff 8

Ibrahim Shaqir

Overview of FY ‘20 and Looking to FY’21 23

Bernadette Juarez

Overview of the SECURE Rule 41

Alan Pearson

FY ‘20 Compliance Activities and APHIS

eFile Update 76

Douglas Grant

Closing 100

Doug McKalip
3

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 P-R-O-C-E-E-D-I-N-G-S

2 (1:06 p.m.)

3 OPERATOR: Ladies and gentlemen, 

4 welcome and thank you for joining Biotechnology 

5 Regulatory Services Stakeholder meeting.

6 Before we begin, please ensure you 

7 open the WebEx chat panel by using the associated 

8 icon located at the bottom of your screen. 

9 If you require technical assistance, 

10 please send a chat to the event producer. Please 

11 note that all lines are muted until the Q and A 

12 portion of the call. We will give you 

13 instructions on how to ask a question at that 

14 time.

15 As a reminder, this conference is 

16 being recorded.

17 With that, I will turn the call over 

18 to Doug McKalip, Senior Advisor with BRS. Doug, 

19 please go ahead.

20 MR. McKALIP: Thank you so much. And 

21 welcome to the BRS Annual Stakeholder meeting for 
4

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 2020. And for those of you in Mountain Time Zone 

2 and West, good morning to you all as well.

3 We are so happy that everybody could 

4 join. We had a large number of science and a lot 

5 of folks on the WebEx this afternoon. And I think 

6 really the highest number of registrants that I 

7 have seen in recent years.

8 The BRS Annual Stakeholder meeting is 

9 somewhat of a holiday season tradition in that we 

10 typically wrap up the end of the calendar year 

11 with this meeting, and we usually would do it 

12 together in the APHIS Headquarters in Riverdale, 

13 Maryland.

14 It’s a chance to greet and shake hands 

15 and catch up with each and every one of you. 

16 We recognize that 2020 is a different 

17 year. And while we regret that we can’t visit in 

18 person, we aim to make this meeting this 

19 afternoon every bit as comprehensive as usual 

20 with all the same policy contents and actions to 

21 share with you.
5

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 For BRS, though, 2020 has meant a year 

2 of less commuting activity, but it certainly has 

3 been a year of more program activity. And there 

4 is a lot to share, and a lot to discuss with all 

5 of you here this afternoon.

6 In terms of the game plan for today, 

7 we’ll kickoff in a moment or two with Ibrahim 

8 Shaqir to talk about some of the new faces and 

9 new staffing that we have on board at BRS partly 

10 the increase of staffing that we have done to get 

11 ready for implementation of our new regulations.

12 Following Ibrahim, we’ll have really 

13 the centerpiece presentation today with our 

14 Deputy Administrator, Bernadette Juarez, 

15 providing the overview of 2020 and a look ahead 

16 to 2021 for BRS.

17 Following Bernadette, Alan Pearson 

18 will talk about some key regulatory issues. Many 

19 of you submitted questions ahead of this meeting, 

20 and Alan will walk through many program specifics 

21 relating to the regulation and address many of 
6

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 the topics that folks submitted in advance.

2 And then, lastly, Doug Grant will 

3 provide a regulatory operation overview for BRS.

4 For any of you who might have had any 

5 technical issues, the APHIS website for BRS does 

6 contain all of the materials for this meeting. 

7 That includes the slide deck presentation and the 

8 agenda and associated materials.

9 So if you are able to take a look at 

10 our website, it is featured front and center 

11 there. And I believe we’re going to post that 

12 web address as well to the chat box to provide 

13 another avenue for you to get to the key materials 

14 for this session.

15 Our intention is not to take any 

16 breaks today. We’re going to try to go straight 

17 through the presentations. And we may need a 

18 moment as we switch presenters to have each 

19 presenter take control of the slide deck.

20 We’ll do our best to monitor the chat 

21 box. So if you have questions and put them in 
7

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 the chat, we’ll try to answer those in turn 

2 following each of the presentations.

3 And we’ll try to handle any questions 

4 that come in writing first.

5 That we recognize not everyone will 

6 have the capability to submit those so after 

7 we’ve gone through written questions, we’ll ask 

8 the AT&T operator to help identify any verbal 

9 questions. And then, we’ll open the phone lines 

10 for those verbal questions as well.

11 In the meantime, if you’re not asking 

12 a question, please make sure that you remain on 

13 mute. 

14 And if we don’t respond to a written 

15 question right away, if I don’t read it right 

16 away, sit tight. It could be that your question 

17 will be answered as we go through the slide deck. 

18 And we’ll make sure that we cover it certainly by 

19 the end of the presentation today.

20 So we want to, again, thank you, for 

21 being here. This is a great chance to share. 
8

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 And to make sure that all of our BRS stakeholders 

2 are up to date with the latest activities that we 

3 have underway.

4 So with that, I’m going to turn it 

5 over to Ibrahim Shaqir who is our Associate 

6 Deputy Administrator for Emerging and 

7 International Programs.

8 Mr. Shaqir participates in the 

9 formulation and in the administration of broad 

10 policies and objectives of APHIS biotech 

11 programs. He works with international 

12 organizations to develop many standards for 

13 biotechnology. 

14 From 2009 to ‘16, Ibrahim was the 

15 Director of the Office of International Research 

16 Programs with ARS. 

17 From 2001 to 2008, he was an 

18 International Affairs Specialist for Middle East 

19 and North Africa as well.

20 Prior to coming to USDA, Ibrahim 

21 worked for the University of Maryland and was 
9

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 also a consultant with the USDA FAS.

2 So, Ibrahim, I’m going to turn it over 

3 to you for your presentation.

4 MR. SHAQIR: Doug, thank you so much 

5 for the kind introduction.

6 And thank you everyone for joining us 

7 this afternoon.

8 It’s always a great honor to be with 

9 you and our stakeholders. And this is an event 

10 that we truly look forward to as Doug mentioned.

11 So now, I’m on the agenda to talk to 

12 you about our addition, our new addition, to our 

13 team in BRS. And we are very excited about having 

14 them and including them on our team.

15 So we have had an active year in 

16 hiring new staff in BRS. BRS had about 11 percent 

17 staff increase in 2020.

18 We were proactively thinking about 

19 staffing in preparation for developing and 

20 implementing the new SECURE rule. 

21 And in anticipating, you know, what 
10

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 to, like, you know, in terms of expectations on 

2 what we need to do and what’s required to meet to 

3 meet our obligations.

4 So I will, again, I’m delighted to 

5 share these names with you. But in advance of 

6 that, I would like to just give you our structure, 

7 a reminder of how BRS is structured.

8 And then, introduce the new staff with 

9 the program area.

10 And I will go with that. Moving the 

11 slides here, and so, first let me talk with, as 

12 I mentioned, how we are structured.

13 We have two main programs in BRS, 

14 Biotechnology Risk Analysis Programs, also 

15 referred to them as BRAP. 

16 And moving BRAP, there are three 

17 branches, Plants Branch and Plant Pests, 

18 Protectants Branch and Plant Evaluation Branch.

19 The second major program is the 

20 Regulatory Operations Programs, ROP, and there 

21 are three different branches. And they’re also 
11

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 in the three different locations as well.

2 Eastern Compliance Assurance Branch, 

3 ECAB, and Compliance Evaluation and Enforcement 

4 Branch, and Western Compliance Assurance Branch.

5 And that’s really the names that we 

6 made programs in BRS but also the four support 

7 service groups and science advisors in the Office 

8 of the Deputy Administrator.

9 And these, you know, important, these 

10 are important function. They keep BRS moving, 

11 and they are the heart of BRS as well in terms of 

12 our function.

13 So there’s the Communications Branch, 

14 the Intergovernmental Operations, and you have 

15 Policy, Program and International 

16 Collaborations, PPIC, and Resource Management 

17 Services.

18 And this is the first part of BRAP. 

19 Many of you probably know and have engaged with 

20 BRAP but by bioregulatory analysis programs that 

21 includes scientists who review detailed 
12

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 information submitted by applicants who want to 

2 move plant and fields and conduct field testing 

3 of organisms developed using genetic engineering. 

4 And they also ask us the potential plant pest 

5 risk and potential environmental impact to inform 

6 APHIS decision making.

7 Within BRAP, really much of the hiring 

8 were in support were basically in BRAP. The first 

9 one that the, you know, the name, we have the 

10 important addition for one of our new branches 

11 which include Dr. Suma Chakravarthy. She’s our 

12 new Plant Evaluation Branch Chief. 

13 She has years of research experience 

14 in molecular biology and manages work related to 

15 implementation of the SECURE rule.

16 We are actually super happy to have 

17 Suma because Suma was one of our AAAS fellows. 

18 And we’re very happy that she came and joined us.

19 Another addition we have Tyler Reid. 

20 And we’re always happy to include our pathway or 

21 entrance in our program.
13

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Tyler Reid is a junior undergraduate 

2 major in agriculture. He is working with BRAP 

3 scientists on documentation reviews. 

4 We, also, are happy to let you know 

5 that we also hired two senior biology scientists, 

6 Dr. Michael Stulberg and Dr. Martha Malapi-Wight. 

7 And both, they came to us from a sister program, 

8 from PPQ. And we’re so delighted to have them.

9 We have also hired eight biological 

10 scientists and that, scientists also on this 

11 slide, Srinivasa Chaluvadi -- and excuse my 

12 pronunciation -- Rebecca Fletcher, Herbert 

13 Eichenseer, Natalie Howe, Ordom Huot, Colin 

14 Murphree, and Sarah Prewitt and Katharine 

15 Swoboda-Bhattarai.

16 So we truly are excited to have them. 

17 They are trained, our new colleagues are trained 

18 experts in genetics and entomology, plant 

19 pathology, root ecology, botany, molecular 

20 biology, agronomy, biochemistry and risk 

21 assessment just to name a few.
14

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 We are very excited to have such a 

2 broad range of scientific and regulatory 

3 expertise to support the nation and assist our 

4 stakeholders.

5 Next, I’ll move onto ROP. And ROP, 

6 our Regulatory Operations Program, has regulatory 

7 and compliance analysts who ensure compliance 

8 with APHIS Regulations through inspections, 

9 evaluating the noncompliance incidents and 

10 overseeing the required supporting.

11 So this is really important too. We 

12 are delighted to introduce to you Dr. Doug Grant. 

13 Doug was our, he’s from, where we were able to 

14 recruit him from within BRS. He was our Staff 

15 and Branch Chief in Fort Collins and now serves 

16 as ROP Director.

17 It is the program’s activities in 

18 ensuring compliance with APHIS biotechnology 

19 regulations.

20 So we’re so super happy. And Doug 

21 Grant will be presenting to you later on.
15

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 We also, I’m happy to introduce 

2 Heather Brown. Also, Heather was with us within 

3 the BRS ROP. And she is at a new capacity now, 

4 a new role. Heather assist stakeholders with 

5 compliance questions, evaluates compliance of 

6 regulatory activities and referrals from the BRS 

7 inspection program. And so, we welcome Heather.

8 The other new hires, we have also from 

9 our sister program, from PPQ, she joins us, 

10 Elizabeth Burns. She joins us from PPQ in 

11 Illinois and will work for BRS from Illinois, as 

12 well, providing oversight of regulatory seed 

13 trials and specialty feeds in the upper Midwest 

14 and facilities -- I’m sorry -- in the upper 

15 Midwest conducting inspections and evaluating 

16 compliance reports.

17 Now also a new hire for our 

18 Communications Branch and Communication Branch 

19 Closed Media. It’s a really important role and 

20 coordinates in BRS communication strategies and 

21 our outreach efforts. She manages the BRS 
16

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 website, conferences, supports strategic and 

2 operational planning and manages BRS response to 

3 Freedom of Information Act per our request and 

4 provides guidance on multiple administrative 

5 procedures as effected by biotechnology 

6 regulations.

7 I’m delighted to introduce to you Dr. 

8 Hannah Hamilton. She comes to us, she comes to 

9 BRS with several years of experience in public 

10 affairs and science communications from the 

11 Department of Interior.

12 She leads the branch effort to 

13 effectively communicate the work of BRS to our 

14 stakeholders and other interested audiences in 

15 the U.S. and around the globe.

16 We are delighted to have Dr. Hamilton. 

17 But also, I want to thank her and her team for 

18 actually for the meeting and making all those 

19 particular arrangements for this event.

20 So thank you, Hannah, for everything 

21 and your team as well.
17

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Next is PPIC group. And PPIC group 

2 conducts legal and policy analysis and also 

3 guides policy development, manages compliance 

4 assistance programs and assists program units to 

5 implement quality management and principles and 

6 practices. And also, very important role in 

7 international coordination and outreach as well.

8 We are delighted to have also our 

9 newcomer, Kayla Knilans. And she is also a AAAS 

10 fellow, and we are delighted to have her and be 

11 able to recruit her to stay and retain her BRS.

12 And so, Kayla coordinates BRS 

13 activities under the trilateral technical working 

14 group with Canada and Mexico and other nations as 

15 well. 

16 She also develops strategies for 

17 engagement for domestic and international 

18 governmental organizations on technical and 

19 regulatory information. 

20 So welcome, Kayla.

21 And next in this group, I’m delighted 
18

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 to also introduce Mr. Russel Duncan. He is on 

2 the long term detailed to BRS from one of our 

3 sister programs for international services, IS. 

4 So he provides technical assistance 

5 for international activities, policy and 

6 engagement, customer care coordination with AFS, 

7 International Services, and supports prior 

8 technology capacity building efforts.

9 We are delighted to have Russell on 

10 our team, and he has been fantastic helping us 

11 with many international aspects of the SECURE 

12 rule and communication outreach.

13 And finally, I just want to add that 

14 we also added new team members to the Resource 

15 Management Services Branch. That is responsible 

16 for all administrative function as it pertains to 

17 human, physical capital, and resource management, 

18 financial management and data management.

19 And we are delighted to have on our 

20 team Djene Sylla who is the program assistant and 

21 provide administrative assistance for Human 
19

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Resource function, fleet, and facility 

2 management.

3 So we welcome Djene.

4 And finally, Mr. Jason Chatman is the 

5 management analyst and work with the other 

6 management team on eFile and other IT functions 

7 as well.

8 So we welcome Jason and he has been 

9 hitting the ground running, working and helping 

10 us with eFile-related issues, and he’s a great 

11 addition to our team.

12 So just to, in summary, we want to let 

13 you know that we are excited. We made staffing 

14 changes for very important reasons, for 

15 implementation for our new rule, the SECURE rule. 

16 We have very trained staff who managed and 

17 coordinated for reviews and evaluations. They 

18 have smoother transition into new role and ways 

19 of doing business. 

20 So even, you know, if we have adopted 

21 to the new work environment during the pandemic, 
20

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 in a way that we have, we hope it has been 

2 seamless for you, our stakeholders.

3 With that, I want to thank you so very 

4 much for your dedication. That concludes my 

5 presentation to you, and I would be happy to 

6 entertain any questions.

7 And for now, I’ll turn it back to 

8 Doug.

9 MR. McKALIP: Thank you so much, 

10 Ibrahim, really impressive to see all the 

11 additional capacity and the number of new names 

12 and new faces that were not part of this meeting 

13 one year ago. 

14 So thank you for that overview.

15 In the chat box, we did have a 

16 question. Would it be possible to have the 

17 presentation? And the answer is yes.

18 The full slide deck from today’s 

19 meeting is available on our website. If you just 

20 go to the BRS website and click at the banner on 

21 the top for the stakeholder meeting, it will take 
21

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 you to a listing of all the resource materials 

2 associated with today’s meeting. We’ll try to 

3 also put that link up in the chat box as well.

4 I don’t see any further questions for 

5 Ibrahim in writing. Just had one to Ibrahim 

6 asking about capacity on the team to work on 

7 microbial regulatory issues which, I know, we do 

8 have some staff expertise already in house on 

9 that. Ibrahim is there anything that you would 

10 like to add specifically about staffing capacity 

11 on microbial regulatory issues?

12 MR. SHAQIR: I do believe we have the 

13 capacity to handle any issues that is microbial 

14 related kind of application or anything of that 

15 regard. 

16 But I will ask Subray if he’s on for 

17 any, if there are specific areas of microbial 

18 related technical issue that that questioner has?

19 MR. HEGDE: Okay. Can you hear me, 

20 Ibrahim?

21 MR. McKALIP: Yes. We can hear you, 
22

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Subray.

2 MR. SHAQIR: Yes.

3 MR. HEGDE: Okay. Yes we have five 

4 staff members who have experiences in the 

5 microbial dedicated to microbes, virus, fungi, 

6 and bacteria. And we are handling most of those 

7 questions already related to microbes within the 

8 community.

9 MR. McKALIP: Great. Thank you, 

10 Subray. I appreciate that input there.

11 Do we have any questions for submitted 

12 verbally by phone. I’ll turn it over to our event 

13 operator to do that check.

14 OPERATOR: Sure, please press pound 

15 two on your telephone keypad to enter the 

16 question queue. You will hear a notification 

17 when your line is unmuted. At that time, please 

18 state your question. Once again, pressing pound 

19 two will indicate that you wish to ask a question.

20 At this time, we have no one in the 

21 queue.
23

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 MR. McKALIP: Okay. Well, Ibrahim, 

2 thank you so much for that overview on staffing. 

3 I really, really appreciate that information for 

4 our team.

5 So we’re going to now shift to you the 

6 second item on our agenda which is the overview 

7 of BRS for 2020 and the look ahead to 2021 which 

8 will come from our Deputy Administrator, 

9 Bernadette Juarez. 

10 Bernadette was appointed Deputy 

11 Administrator in August of 2019. It’s really 

12 impossible to believe that it was that recently. 

13 It really seems like much more in terms of the 

14 amount of action which I’m sure Bernadette will 

15 be covering. 

16 Prior to this appointment, Ms. Juarez 

17 served as deputy administrator for animal care 

18 since 2016, and she joined APHIS in 2009 first as 

19 Investigative and Enforcement Services Deputy 

20 Director for nearly five years and then as 

21 Director starting in 2013.
24

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Before coming to APHIS, she began as 

2 a trial attorney with USDA’s Office of General 

3 Counsel from 2002 to 2009. And she is originally 

4 from the very great and beautiful State of New 

5 Mexico.

6 So Bernadette, I’m going to hand it 

7 over to you for the next agenda item.

8 MS. JUAREZ: Thanks, Doug. I 

9 appreciate that introduction. It has been a busy 

10 16 months, and I look forward to sharing with you 

11 what we’ve been working on over the past year 

12 since we last visited in December.

13 Doug mentioned earlier that on our 

14 landing page for the meeting we posted a number 

15 of materials. One of those first pieces of 

16 material that I’d like you to take a look at when 

17 you have time is BRS by the Numbers. 

18 It’s a one-page document that provides 

19 a nice overview of our key accomplishments during 

20 this year many of which you’ll hear a little bit 

21 about today. But if you’re looking for a nice 
25

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 snapshot of what BRS delivered in terms of 

2 services in Fiscal Year ‘20, that’s a great place 

3 to look.

4 A lot of our focus in ‘20 at Fiscal 

5 Year ‘20, was on finalizing the SECURE rule. It 

6 was issued in May 2020. 

7 We have a variety of materials on our 

8 website that provides an overview of the SECURE 

9 rule both from a textual perspective and a 

10 presentation perspective. 

11 We’ve also posted frequently asked 

12 questions on our website about the SECURE rule. 

13 I’ve included the link to those materials in my 

14 presentation. If you go to our website, you’ll 

15 see them there. 

16 You can view the presentation and 

17 click directly on that linking and get right to 

18 them if you’re interested.

19 One of the first parts of the SECURE 

20 rule to take effect were the exemptions and the 

21 method by which developers can seek confirmation 
26

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 that a plant meets the criteria or one of the new 

2 regulatory exemptions in the SECURE rule. 

3 Those provisions took effect in August 

4 of 2020. We had a number of technical webinars 

5 before those provisions took effect to make sure 

6 that the stakeholder community had a good sense 

7 of how the exemptions work under SECURE and also 

8 the methods by which they could seek confirmation 

9 that their product meets the criteria for 

10 exemption.

11 We developed guidance materials and 

12 frequently asked questions and posted them on our 

13 website. The link that you see there will take 

14 you right to the material for your information as 

15 well.

16 Part of standing up the new exemptions 

17 in the SECURE rule for plants developed using 

18 genetic engineering meant to retiring one of our 

19 legacy processes known as the "Am I Regulated" 

20 process. 

21 That was a nonregulatory method that 
27

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 we maintained for developers to provide us and 

2 learn whether or not their product was subject to 

3 the regulations. 

4 We’ve announced to our stakeholder 

5 community that we would stop accepting requests 

6 using that method in June 2020. And we have now 

7 concluded our responses to all of those "Am I 

8 Regulated" requests that were either pending in 

9 the queue or that we received as part of our 

10 closeout of that process. 

11 Collectively we responded to over 80 

12 inquiries this year. 

13 You can find all of those incoming 

14 inquiries along with our responses by following 

15 that link on our website. 

16 As part of the SECURE rule, the folks 

17 who did submit an inquiry and received a response 

18 and learned that their plant was not covered by 

19 the regulation,

20 that determination maintains and 

21 carries forward or is grandfathered in under the 
28

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 SECURE rule. That determination applies to that 

2 specific developer and that particular plant or 

3 organism that they were writing about in that 

4 inquiry.

5 So if you’d like to take a look at any 

6 of those, you can certainly find them by 

7 following the link in the presentation.

8 Another important component of the 

9 SECURE rule exemption involve Plant-Trait10 Mechanism of Action combinations that we 

11 previously evaluated and determined were not 

12 regulated under the prior regulations.

13 As part of the SECURE rule, we 

14 developed a Plant-Trait-Mechanism of Action table 

15 so that folks know those combinations that would 

16 remain exempt under the SECURE rule. And we 

17 posted it on our website.

18 We still owe a small update to that 

19 table to include insect resistant traits so that 

20 developers have a good sense of how those 

21 exemptions will work for the Plant-Trait-
29

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Mechanism of Action associated with insect2 resistant traits.

3 We hope to do that soon. And when we 

4 do, we’ll be sure to let you know of our update 

5 to that Plant-Trait-Mechanism of Action table.

6 So that was sort of the first stage of 

7 implementation of the SECURE rule. 

8 The next stage comes in April 2021. 

9 In April 2021, we will begin to stand up the 

10 regulatory status review process for certain 

11 types of plants. 

12 We will also be implementing the new 

13 permitting requirements in the future rule as we 

14 look forward to sharing an overview of our 

15 conceptual thinking in terms of guidance for 

16 submitting requests for regulatory status 

17 reviews. 

18 Dr. Alan Pearson will be spending 

19 about half of his presentation today walking 

20 through the general thinking for that guidance 

21 document. 
30

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 We really look forward to receiving 

2 questions from you in terms of our thoughts. We 

3 want to make sure that by the time we get to the 

4 point of sharing, that document, in writing, that 

5 we have shored up any potential gray areas and 

6 make sure that it’s useful for both internal and 

7 external users. So he’ll be talking to you about 

8 that.

9 Another important part of this new 

10 rule that I should have mentioned before moving 

11 on to the Regulatory Management Review process 

12 has to do with our ability to add additional 

13 exemptions for plants with additional 

14 modifications that would meet the criteria for 

15 exemption because they were otherwise achievable 

16 through conventional breeding. 

17 This is one of the key components of 

18 the exemption section of the SECURE rule that 

19 allows us to ensure that our exemptions remain 

20 current with technology and advancements in 

21 conventional breeding. 
31

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 We have developed a high level 

2 overview of the guidance document that we’d like 

3 to share with you on how to submit proposals for 

4 expanding or listing additional plants with 

5 modifications that would also qualify for 

6 exemption. 

7 Again, Dr. Alan Pearson will be 

8 visiting with us in just a few moments about our 

9 thinking on that topic. We certainly look 

10 forward to your feedback and questions during 

11 that session.

12 Lastly, I did mention that the 

13 permitting practice would take effect in April. 

14 We haven’t yet turned our attention to developing 

15 guidance for that new process. We know it’s 

16 important to you. It’s important to us. 

17 We want to make sure that when we have 

18 that guidance in place it will help facilitate 

19 not only the transitions that were made to the 

20 SECURE rule but also to our new information 

21 management system, eFile. 
32

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 We’ll provide you with an update on 

2 where we stand with regard to our transition to 

3 that new information management system that will 

4 soon become the sole method by which developers 

5 will submit applications for permits.

6 We also are excited to be able to fill 

7 the component into that new information 

8 management system that will allow developers to 

9 submit requests for confirmation that a plant 

10 meets the criteria for regulatory exemption as 

11 well.

12 In the future, we envision that system 

13 being further developed so that any regulatory 

14 status review request would also come through 

15 that platform so sanctions for additional work in 

16 that regard.

17 We’ve spent, also, in terms of 

18 implementation of the SECURE rule, quite a lot of 

19 time thinking about our international strategies 

20 and outreach to make sure that our trading 

21 partners around the world have a good sense of 
33

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 USDA’s Policy approach for handling plants 

2 developed using genetic engineering.

3 Following the issuance of the SECURE 

4 rule, we shared talking points and materials with 

5 98 offices to our foreign Ag service and 28 

6 additional offices with our international 

7 services.

8 We’ve had a variety of multilateral, 

9 bilateral and regional meetings for sharing 

10 encouraged science through this approach.

11 Our vision is to have greater 

12 harmonization and tell countries around the world 

13 to view this product so that we can help 

14 facilitate development, innovation, and also 

15 export those products that are approved using 

16 genetic engineering.

17 We’ve met with several countries. 

18 It’s even listed there, Canada, Mexico, Brazil, 

19 Latin American countries, Taiwan, Korea, Dubai, 

20 Japan. 

21 And we have upcoming interaction plans 
34

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 again to circle back with Korea, meet with EEU. 

2 We have plans to visit with Spain and Portugal 

3 and the Latin American countries and them too.

4 So we certainly look forward to 

5 continuing to share information on the SECURE 

6 rule in 2021. Even though we haven’t been able 

7 to do so in person, we really worked to improve 

8 our strategy for using virtual meetings to convey 

9 and share this information and have learned a lot 

10 through that process.

11 Finally, I wanted to share with you an 

12 update on the work that’s been in our pipeline.

13 We haven’t had the with respect to 

14 final determination of nonregulated status in 

15 2021. We haven’t reached the final solution for 

16 any, but we’re getting very close on several. 

17 In 2020 itself, we had one involving 

18 the Simplot Potato you see there. 

19 We’ve completed or closed out the 

20 comments period for draft plant pest risk 

21 assessments or draft EAs or extensions through
35

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 products. But my Monsanto Lygus cotton, Westhoff 

2 petunia and the Pioneer enhanced yield corn. 

3 Again, those are kind of in the middle 

4 stage, and we look forward to getting those to 

5 the finish line sometime soon. 

6 We also have an open comment period 

7 for Pioneer there with their one product as well.

8 We’ve published several petitions for 

9 comment. We’ve got closed comment periods now on 

10 four petitions that you see there and one open 

11 comment period for Pioneer with an insect and 

12 herbicide resistant maize.

13 So there was, admittedly, a little 

14 juggling that we had to do to, both, push the 

15 SECURE rule out the door and continue to push 

16 petitions through the pipeline. 

17 I think we see from the distribution 

18 of work here that we have several that are coming 

19 to fruition and others that are in the queue to 

20 push through the process. 

21 So we look forward to doing a little 
36

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 bit of catchup work early in the fiscal year and 

2 continue to move petitions along in the 

3 administrative process and review process in 

4 2021.

5 Finally, one of the shadow projects 

6 that we’ve been working on in BRS with 

7 contemplating how USDA may evaluate animals 

8 developed using genetic engineering.

9 In late November, November 26th, USDA 

10 submitted an advanced notice of proposed 

11 rulemaking to the Office of Management and Budget 

12 that would describe the regulations for the 

13 movement of animals modified or produced using 

14 genetic engineering.

15 It brought this conceptual framework 

16 that would partner with another sister agency 

17 within USDA, the Food Safety Inspection Service, 

18 so that USDA could provide a one-stop shop for a 

19 certain animals known as amenable species 

20 developed using genetic engineering that are 

21 intended for agriculture purposes. 
37

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 This advance notice of proposed rule 

2 making remains under OMB review. So we’re not 

3 able to discuss much of the content of that 

4 proposal at this point. And this rulemaking --

5 we look forward to that material being publish so 

6 that you can take a look at what additional 

7 business line we may have in the future and 

8 seeking your feedback on the contemplated 

9 regulatory framework that we describe there.

10 So that’s what we’ve been up to in BRS 

11 over the past 12 months, and for me, 16 months. 

12 Doug, you’re right it does feel like a longer 

13 period than 16 months, but I’m happy that we had 

14 a strong hustle and were able to get some of the 

15 things out the door and cooking under hot heat.

16 MR. McKALIP: Great. Thank you, 

17 Bernadette. We did have a question submitted in 

18 writing which was coming from Ray Dobert asking 

19 what has been the general feedback from other 

20 regulators regarding the SECURE rule? What 

21 concerns have been voiced on the elements of the 
38

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 rule?

2 MS. JUAREZ: Thanks. One of the steps 

3 that we took in the development of the SECURE 

4 rule was really working with our fellow 

5 regulators like EPA and FDA to gain as much 

6 alignment and consensus and try to pass forward 

7 as possible.

8 We’ve received positive feedback from 

9 our colleagues for that outreach and connection 

10 prior to issuing the final rule for those who 

11 have an interest in some of the work that EPA 

12 does, you know that they published a proposed 

13 rule to provide additional exemptions for certain 

14 types of PIP. And we looked to harmonize 

15 terminology between the two rules, our SECURE 

16 rule and their PIP rule. 

17 So I think what you will see moving 

18 forward is our continued effort to promote 

19 alignment within the USG particularly in terms of 

20 the handling of products using genetic 

21 engineering and to making it easier or wherever 
39

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 possible for developers and stakeholders to 

2 navigate those processes. 

3 And so, we have overall positive 

4 feedback to the SECURE rule. Lots of interest in 

5 understanding the scientific underpinnings of how 

6 we established our regulatory exemptions in 

7 particular. We’ve had lots of discussions in 

8 that area.

9 And of course, our partners are 

10 interested in seeing our phased implementation of 

11 the rule as well.

12 MR. McKALIP: Great. Thanks, 

13 Bernadette. Yes. And I totally agree having 

14 gone on a lot of those international trips that 

15 the response has been very, very positive from 

16 folks.

17 Another question submitted in writing 

18 might even get to perhaps an oversight in our 

19 slide deck. It’s asking about China’s connection 

20 on our outreach for SECURE.

21 MS. JUAREZ: Oh, you know, I don’t 
40

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 recall that we have had a meeting with China yet 

2 on SECURE. And certainly, it’s just not 

3 something that we’re opposed to doing. 

4 It’s just a matter of moving along on 

5 in the process. Some of the countries that we’ve 

6 met with are countries that expressed interest 

7 early on in meeting with us. And that was 

8 prioritized and getting back with them as quickly 

9 as possible.

10 And so, as part of our international 

11 strategy for 2021, we’re developing a framework 

12 for how we’ll approach that. And I’ll be sure to 

13 take a look at where China might fall in that 

14 list.

15 MR. McKALIP: Great. Operator, if 

16 there are any questions submitted verbally, 

17 please open up the lines for them.

18 THE OPERATOR: Once again, please 

19 press pound two on your telephone keypad to enter 

20 the question queue.

21 At this time, we have no one in the 
41

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 queue.

2 MS. JUAREZ: Okay. Thanks, Doug. 

3 Then I will turn it back to you.

4 MR. McKALIP: Great. And thank you, 

5 Bernadette. I really appreciate that overview.

6 Okay. So we’re going to move into our 

7 next agenda item which relates to some of the 

8 more specific regulatory issues associated with 

9 SECURE and so forth.

10 So we will now be joined by Alan 

11 Pearson, our Associate Deputy Administrator of 

12 BRS.

13 Alan was previously the BRAP Branch 

14 Chief, and he was originally hired on to BRS in 

15 2009 as the biological scientist. He was a AAAS 

16 science fellow from 2003 to 2004. 

17 He did his post doc at Mass General 

18 and Harvard Medical School and has a PhD from MIT 

19 and an undergraduate degree from Brandeis. 

20 So, Alan, hopefully, you’re in the 

21 queue. I’m going to turn it over to you for the 
42

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 next portion of the slide deck.

2 MR. PEARSON: Okay. Thank you, Doug. 

3 And welcome everybody to our meeting. It’s my 

4 pleasure to talk to you today about a couple of 

5 the guidance documents that we are preparing and 

6 will be making available for your review soon.

7 I’m going to talk about two guidance 

8 documents. And the first I’m going to talk about 

9 the Guidance for Preparing Proposals to Exempt 

10 Plants with Additional Modifications from the 

11 SECURE rule. 

12 And second, I’ll give an overview of 

13 the Guidance on Preparing Requests for Regulatory 

14 Status Review.

15 So starting with the first item, the 

16 Guidance for Preparing Proposals to Exempt Plants 

17 with Additional Modifications from the 

18 regulations.

19 As you know, we three express, no we 

20 have an expressed exemption in the rule for 

21 plants that could have been produced through the 
43

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 conventional breeding. 

2 And we’ve identified three specific 

3 types of modifications that a plant can have any 

4 one of. And qualify for exemption. 

5 In addition, we’ve developed a process 

6 whereby the administrator can list additional 

7 modifications that a plant can have and qualify 

8 for the exemption. 

9 And we can either initiate such a 

10 listing modification ourselves, or we can, 

11 respond to a request someone from outside of 

12 APHIS for that.

13 So this guidance is really meant to 

14 let you know what comes with information you 

15 would need to provide if you wanted to request 

16 that we list an additional modification plants 

17 can have and qualify for the exemption.

18 So I will brief you through some of 

19 the required information and talk to you a little 

20 bit about the process.

21 There are, briefly, the first I want, 
44

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 you know, you need any contact information and 

2 really the key point is that clear description of 

3 what the additional genetic modification and 

4 modifications that the plant can contain and 

5 qualify for an exemption.

6 For example, perhaps a specified 

7 number of changes that are achievable in 

8 cultivated plants. 

9 So perhaps you want to propose a 

10 specified number of changes achievable in a 

11 particular plant species or a type of 

12 modification rather than one of the ones that’s 

13 already listed in Part 340.1(b)(1-3). 

14 Along with that, you need to provide 

15 us with a statement of a factual grounds that 

16 demonstrate that plants contain the proposed 

17 modification can be achieved in conventional 

18 breeding and provide supported scientific 

19 literature or publicly available information that 

20 would support those factual grounds as well as 

21 any information you may know that would be 
45

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 unfavorable to having that modification to the 

2 list, that modification plants can have and 

3 qualify for exemptions.

4 Our decision standard when we say 

5 could be achieved through conventional breeding, 

6 means that the genetic modification is 

7 practically achievable through the conventional 

8 breeding methods in the plant. 

9 For example, evidence that multiple 

10 desired traits or genetic modifications could be 

11 introduced in a plant on a practical basis would 

12 meet that standard.

13 We’re unlikely, on the other hand, to 

14 adopt an invention for plants that contains 

15 specifically nearly implausible modifications.

16 So that’s just to make clear and that 

17 standard really comes from what we laid out in

18 the preamble to the SECURE rule by what were meant 

19 by the terms to be achieved through conventional 

20 breeding.

21 Our process is that you would submit 
46

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 proposals electronically via a mailbox listed 

2 here, an email address (b)(4)

3 exemptionrequests@usda.gov.

4 If there is not sufficient, publicly 

5 available information supporting the proposal. 

6 Or if after we review it, we disagree that plants 

7 containing the modification or modifications 

8 could be achieved through conventional breeding 

9 method, then we’ll return the proposal to you and 

10 provide our reasons for returning it to you in 

11 writing.

12 On the other hand, if we determine 

13 that plants containing the modification could be 

14 achieved through conventional breeding methods, 

15 then we’ll publish the proposal and supporting 

16 information in the Federal Register for Public 

17 Comment. 

18 And after reviewing that comment, 

19 we’ll publish a subsequent notice in the FR

20 announcing our final determination on the 

21 proposal that’s been sent to us.
47

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 We’ll complete our review and make our 

2 final determination. And in 12 months of 

3 receiving all the required information, we’ll 

4 list it unless there’s circumstances that could 

5 not have been reasonably anticipated.

6 And finally, we recommend that before 

7 you submit your, you know, if you are intending 

8 to submit a proposal and you’ve never submitted 

9 one before, that you talk with us first just to 

10 make sure that you fully understand what we’re 

11 looking for. 

12 And we understand what you are 

13 intending to be submitting so that we can make 

14 sure that the process runs smoothly.

15 Finally, the Guidance Document that we 

16 are going to be making available on our website 

17 will include a couple of examples of proposals.

18 And these are the examples based on 

19 the modifications that are already listed in the 

20 SECURE rule.

21 So that concludes the overview of the 
48

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 guidance we’ll be making available on proposing 

2 additional modifications that plants can have and 

3 be exempt from SECURE.

4 And the rest of my presentation and 

5 the bulk of the presentation, I’m going to give 

6 you an overview of the guidance that we’re 

7 developing for requesting a regulatory status 

8 review.

9 We’re in the process of completing 

10 that guidance now. And we want to provide the 

11 overview today and take any questions or feedback 

12 you may have. 

13 And also, let you know that there will 

14 be opportunity to comment further on this when we 

15 publish the guidance.

16 So to begin with as you know if a plant 

17 does not meet one of the regulatory exemptions 

18 listed in the SECURE rule, then the developer can 

19 seek a regulatory status review for that plant to 

20 determine whether or not it’s regulated.

21 And in the regulatory status review, 
49

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 APHIS evaluates whether a plant pest risk posed 

2 by the plant is any greater than that posed by 

3 its comparator plant. 

4 We based that on looking at the 

5 biological properties of the plant looking at its

6 trait or a new characteristic that’s been

7 conferred on the plant and looking at the 

8 mechanism of action or how the modification 

9 caused the new trait to occur. 

10 I just want to review a few important 

11 definitions that you should know when thinking 

12 about a regulatory status review request.

13 The first is the definition of 

14 comparator plant which is essentially the plant 

15 that’s used as a comparison or a reference for 

16 the plant developed using genetic engineering to 

17 determine if that plant, the plant being 

18 evaluated poses an increased plant pest risk.

19 Typically, a comparator plant is a 

20 plant that hasn’t been developed through genetic 

21 engineering and from which the plant being 
50

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 evaluated is derived.

2 However, the comparative plant can 

3 also be a plant that was developed using genetic 

4 engineering if the comparator has been -- if 

5 APHIS has already determined that comparator 

6 plant is not regulated under part 340, and, or if 

7 it’s determined to be the most appropriate base

8 line for comparison on the plant subject to the 

9 RSR request.

10 The other three terms are all defined

11 in the regulations themselves, the definitions of 

12 trait, definition of mechanism of action, and the 

13 definition of plant pest risk. 

14 And as we explained in our in our 

15 Confirmation Guidance.

16 When you’re thinking about a trait and 

17 the trait sometimes referred to as a phenotype, 

18 a phenotypic trait.

19 It’s not a whole station. It’s the 

20 result of the underlying genotype of the plant, 

21 and its interaction with the environment.
51

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 And so, we’ll make those plants that 

2 are in the guidance.

3 Before turning to the information 

4 requirements, I wanted to go through some 

5 information on the process, the RSR process which 

6 is really a one- or two-step process depending on 

7 the plants that we’ve received a request for.

8 So evaluation in step one where we 

9 receive the initial request, and we start in step 

10 one that evaluation looks at the characteristics 

11 of the plant relative to the comparator who 

12 identify whether it is a plausible pathway to 

13 increased plant pest risk.

14 And that is where we ask is there a

15 scientifically plausible hypothesis by which a 

16 trait and the mechanism of action in the plant 

17 can change any of four factors in the way that 

18 can lead to increased plant pest risks.

19 Either the distribution density or 

20 development of the plant or its sexually 

21 compatible relatives if there are any sexually 
52

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 compatible relatives. 

2 We look at the production, creation or 

3 enhancement of a plant pest or a reservoir for a 

4 plant pest. 

5 We look at harm to non-target 

6 organisms beneficial to agricultural even if you 

7 consider immediate impacts of a plant and its 

8 sexually compatible relatives and whether those 

9 could contribute to increased plant pest risk.

10 In general, you will complete step one 

11 in 180 days from receipt of request that meets 

12 the information requirements.

13 There are -- unless there’s, and 

14 again, some certain things that can’t reasonably 

15 be anticipated. 

16 There’s 180 days to receive a 

17 completeness check. You’ll know more in two 

18 weeks’ time. 

19 And then, once a request is deemed

20 complete, our risk assessors review will have 

21 sufficient information from the requestor in 
53

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 order to complete step one of the process.

2 Now if APHIS does not identify a 

3 plausible pathway to increased plant pest risk 

4 during its first step, then the plant would not 

5 be subject to the regulations. And we would post 

6 the plant, the trait and mechanism of action on 

7 our website.

8 I know that we had comments during the 

9 -- on our proposed rule about confidential 

10 business information. And we of course will

11 honor any confidential business information that 

12 is claimed in the request assuming that we 

13 accept the submitted CBI claims, and so I posted 

14 those in our MOA -- clearly in that context.

15 If in step one we do identify a 

16 plausible pathway to increased plant pest risks, 

17 then we’ll provide feedback to the requestor 

18 about the plausible pathway that we’ve identified 

19 and the type of additional information, if any, 

20 that we might need to complete a plant pest risk 

21 assessment in the second step of the process.
54

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 And at that time, they have a 

2 conversation with the developer to make sure, or 

3 the requestor, to make sure they understand our 

4 specific areas of concern so that they can 

5 evaluate the next step that they wish to take.

6 And there are various options that a 

7 requestor could choose from. They may elect to 

8 take no further action and simply be done.

9 They may elect to request a permit 

10 from us to allow movement and/or confined 

11 release.

12 They may submit a formal request that 

13 we complete a plant pest risk assessment as part 

14 of step two of the RSR process.

15 Or they could pause the RSR process 

16 and simply ask us to just hold it there until 

17 they’re ready to proceed.

18 And I want to add that, you know, the 

19 requestor can also submit a request that APHIS 

20 complete a PPRA and also a obtain of permit at 

21 the same time so that they can be doing work with 
55

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 that plant while we’re continuing the RSR 

2 process.

3 They may choose to obtain a permit and 

4 pause the RSR process while they collect 

5 laboratory and field data to support a plant pest 

6 risk assessment.

7 There are various options that a 

8 requestor can take once we completed step one, if 

9 we do identify a plausible pathway to increased 

10 plant pest risk.

11 In step two, if we identify a 

12 plausible pathway to increased plant pest risk 

13 and the requestor wishes to proceed into step 

14 two, then we’ll conduct a plant pest risk 

15 assessment to evaluate the identified pathway and 

16 the factors of concern in order to determine the 

17 likelihood and consequence of the plausible 

18 increased plant pest risk.

19 We will publish this PPRA in the 

20 Federal Register along with any applicable 

21 environmental analyses when we make a preliminary 
56

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 finding that the plant is unlikely to increase a 

2 plant pest risk.

3 Now at that time, we will solicit any 

4 comments from the public which we’ll then 

5 evaluate and determine if there’s information 

6 that impacts our PPRA.

7 If we find that the plant’s unlikely 

8 to pose an increased plant pest risk, then the 

9 plant would not be subject to regulations at that 

10 point.

11 And of course as the plants where we 

12 made such a finding after step one, the plant 

13 trait and then they would go onto our PT MOA table 

14 so that plants would have the same PT MOA would 

15 qualify for exemption from the SECURE rule.

16 If APHIS is unable to find that the 

17 plant is then likely to pose an increased plant 

18 pest risk, then the plant would remain regulated.

19 In this process, we anticipate 

20 generally completing within 15 months of 

21 receiving a complete initial request. This 
57

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 includes a 30-day completeness review for any 

2 data that we’ve requested or the developer has 

3 submitted.

4 It excludes any pauses in the process, 

5 and I’ll discuss pauses in a moment.

6 At any time during the RSR process, 

7 the developer or requestor has the opportunity to 

8 submit additional information or data to aid in 

9 our evaluation of the factors that we’ve 

10 identified. 

11 And in addition, if we are unable to 

12 make a finding that a plant is unlikely to pose 

13 an increased plant pest risk, a requestor can 

14 later submit a request for re-review of the plant 

15 if they have additional scientifically valid 

16 evidence related to plant pest risk.

17 For the re-review, you will 

18 essentially be starting at step two again. We 

19 would have already identified the plausible 

20 pathways of harm in step one.

21 So we would not be starting the 
58

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 process earlier from the beginning if a re-review 

2 is requested because we had already found we were 

3 -- that we weren’t able to find it was unlikely 

4 to pose an increased plant pest risk.

5 In addition, though, anyone can 

6 request a re-review based upon scientifically 

7 valid evidence related to plant pest risk. They 

8 would need to have that evidence in front of us

9 in order to act on any request for re-review.

10 I mentioned pausing the RSR process. 

11 APHIS will pause the process after step one until 

12 we receive a response from the requestor as to 

13 how they want to proceed.

14 So here I’m talking about, if in step 

15 one, you have identified a plausible pathway to 

16 increased plant pest risk, at that point we’ll 

17 pause the process until the requestor tell us 

18 that they want us to proceed with step two of the 

19 RSR process and then conduct the PPRA.

20 We’ll also pause the process while 

21 awaiting a response from a requestor to the 
59

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 completeness review that we undertake at the 

2 beginning of step two in the process.

3 In our experience with petitions and 

4 considering the possibility that requestors may 

5 not have collected all of the data necessary to 

6 support a PPRA, at the time that they request us 

7 to conduct one, stopping the clock here for a 

8 while or pausing the process while waiting 

9 response to this completeness review, this would 

10 also be a good option.

11 It avoids putting undue time pressure 

12 on requestors to generate data or reanalyze 

13 existing data and, thereby, enables us to make 

14 sure we’ve got a complete data package. And then, 

15 the requestor is ready to proceed and then we’ll 

16 continue with the RSR process.

17 We’re only going to conduct one round 

18 of completeness review at step two. After that, 

19 we will proceed with conducting a PPRA with the

20 data that has been submitted to us in response to 

21 end the completeness review.
60

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 The requestor should recognize that we 

2 could conclude that we are unable to reach a 

3 finding of unlikely to pose an increased plant 

4 pest risk based on the currently available data.

5 If they ask us to proceed and haven’t 

6 clearly provided us with all of the data that 

7 we’ve indicated would be needed, when we send out 

8 the results of our completeness review.

9 Of course, if that happens, again a 

10 requestor could submit a request for re-review 

11 after that.

12 A requestor can request a pause in the 

13 RSR process at any time. So it’s not just APHIS 

14 to pause the process, the requestor can request 

15 the pause in the process, for instance, as I 

16 mentioned with data from the lab or data that is 

17 given to inform a PPRA then the requestor can 

18 pause the process until they provide that data to 

19 APHIS.

20 Now, I am going to turn to the 

21 information that’s required in an RSR request, we 
61

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 laid this out at a high level in the proposed, in 

2 the final rule and the preamble to the final rule.

3 And I’ll go into some more detail 

4 here. First, of course, we need your name, 

5 organization and so on the -- if you had made a 

6 CBI statement. That is whether you are claiming 

7 CBI, or there’s no CBI claim.

8 And if there is a CBI claim with CBI 

9 justification, the scientific name of the 

10 comparator plant or the RSR, the genotype of the 

11 modified plant including a detailed description 

12 of the differences in genotype between the 

13 modified plant and the unmodified plant, and a 

14 detailed description of the new trait.

15 And I’ll step through those last two 

16 bullet points in more detail now.

17 So in terms of genotypic information, 

18 if genetic material is inserted, you need to 

19 provide the DNA sequences of the inserted 

20 material, as well as an annotation of the 

21 inserted material that includes the following 
62

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 items for each component of the construct or 

2 constructs you are using.

3 The nucleotide position of a construct 

4 of that component, the name of the component, for 

5 example, 35S promotor or catalase, or nos 

6 terminator or noncoding spacer. 

7 Plus the donor organism or source from 

8 which a component has been obtained, and then a

9 short description of the function of that 

10 component and like for examples here, if it’s an 

11 enzyme involved amylose synthesis or it confers 

12 glufosinate resistance or it’s a native promoter 

13 or it’s nopaline synthase terminator.

14 The specified sequence information is 

15 needed by APHIS in order to confirm the intended 

16 trait or traits at the molecular and genetic 

17 level. And to better understand the mechanism of 

18 action, for purposes of assessing the potential 

19 for plant pest risks in any of the modification 

20 or modifications. And also if relevant to help 

21 us assess similarity of previously reviewed 
63

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 plants.

2 The other item named donor organism 

3 source and a short description of the function 

4 are really similar to the kinds of information 

5 that developers are already providing in permit

6 applications.

7 So developers of these kinds of plants

8 who have obtained permits or authorizations or 

9 any notification from us in the past. We’ll 

10 already be very familiar with the kind of 

11 information we are asking for here when we talk 

12 about name, donor organism, and short description 

13 of the function.

14 In addition, if genetic material is 

15 inserted, it’s provided with any publicly 

16 available sequence identification number or 

17 protein accession number or enzyme commission 

18 number. Now, we know that that may not be 

19 publicly available, but if it is publicly 

20 available, it will be provided in the request.

21 Any promotors or regulatory elements 
64

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 should be identified as in the case of promoters 

2 or subscription of abuse of or developmental or 

3 tissue specific, and if its developmental or 

4 tissue specific, describe the stage and/or 

5 tissues in which the promoter is intended to be 

6 active.

7 Also if there are sequence alterations 

8 in the genetic material that you’re inserting 

9 relative to the sequence in the donor organism, 

10 then identify the nature and purpose of those 

11 sequence alterations such as graft or codon 

12 optimization or changing the binding site of an 

13 enzyme, and provide us with an alignment with the 

14 sequence of the unmodified in the donor organism.

15 If genetic material is not being 

16 inserted into the organism, then identify the 

17 genes or genomic regions that have been modified 

18 or the functions that have been modified and 

19 provide the sequence of the entire modified 

20 region including alignment with the unmodified.

21 Turning to the required information on 
65

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 the description on the new trait, in that 

2 category, provide the purpose and the intended 

3 phenotype of the new trait including any expected 

4 differences from the phenotype of the comparator.

5 Provide any available information 

6 from the mechanism of action by which the 

7 intended trait is conferred. That is the 

8 biochemical process by which the genetic 

9 modification leads to the desired trait or 

10 phenotype.

11 And provide us with any expected 

12 changes in metabolism, physiology and/or 

13 development due to the trait or the genetic 

14 modification to the extent that you know them.

15 And you’ll notice I’m saying expected 

16 changes. They’re not -- this isn’t to say 

17 requests were up at step one in the process were 

18 not required that you have undertaken a full 

19 phenotypic product ---, but rather that you 

20 provide us with information on what the intent, 

21 intended phenotype is and what other phenotypic 
66

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 changes, the changes in the paddles and so on to 

2 be expected as a result of the modification, to 

3 the extent that is known.

4 So in descriptions, these are just a 

5 couple of examples of descriptions of the new 

6 trait. For instance, the trait would be 

7 herbicide resistance, the phenotype, resistance 

8 to glyphosate and the mechanism of action listed 

9 as an insensitive form, EPSPS with a decrease

10 binding affinity of glyphosate.

11 Or to take another example, a trait 

12 might be an altered tuber amino acid profile. A 

13 phenotype is reduced asparagine or reduce 

14 asparagine levels. And the MOA is a potato tuber15 specific double-stranded RNA-mediated 

16 degradation of asparagine synthetase-1 gene 

17 transcript decreasing protein level and resulting 

18 in reduced version conversion of glutamine to 

19 asparagine in tubers.

20 And to form insight into these MOA 

21 descriptions, you can also look at PT MOA tables 
67

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 where we provide short description of the 

2 mechanism of action for all of the various plants 

3 that we have due regulated under the prior 

4 regulation and which are now eligible where those 

5 plant trait MOA combinations are eligible for 

6 exemption from SECURE.

7 We also list some optional information 

8 that you can provide if you wish. This is 

9 additional information that may be submitted.

10 But this information really should be 

11 limited when you’re first submitting an RSR 

12 request in step one. It should be limited to 

13 that which informs the initial evaluation that is 

14 under taken in step one.

15 So for example, you could let us know 

16 whether the MOA is identical or similar to a 

17 previously reviewed MOA and provide us with the 

18 explanation of the similarity. 

19 You could rely on additional 

20 information on how the genetic material or its 

21 product participates in or interacts with 
68

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 metabolic, physiological or developmental 

2 processes in the plants or other organisms. 

3 Or any other information that you 

4 think would help us to complete that first step 

5 in the process.

6 Now additional, if you submitted 

7 additional information that actually pertains to 

8 a plant pest risk assessment in step two, we will 

9 not review that information unless we’ve 

10 identified a plausible pathway to plant pest 

11 risk.

12 And, ideally, I would prefer that you 

13 not submit that kind of information to us until 

14 you ask us to undertake the PPRA.

15 In order to have an objective analysis 

16 for step one. It can reach a decision that not’s 

17 subject to any challenges, but it can’t be 

18 reviewed information in a manner that can 

19 constitute the plant pest risk assessment that we 

20 would be carrying out in step two.

21 Additionally, we really want to avoid 
69

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 slowing down the completeness review in step one 

2 where we’ve indicated that we would undertake 

3 that review in ten days. 

4 If we have voluminous extra 

5 information that we end up receiving we would 

6 then have to kind of go through that information 

7 to figure out which is relevant to step 1, which 

8 isn’t and parse all that out and that would slow 

9 the process down. 

10 After we’ve completed step one, if we 

11 find that a PPRA would be required, then at that 

12 point a requestor can submit additional 

13 supporting data or at any time after that as well. 

14 They can support, they can submit 

15 additional supporting data up until the time when 

16 we make our final determination.

17 In that, in getting that additional 

18 information to support step two, the data 

19 submission should be limited to those that 

20 address the plausible pathways to increase plant 

21 pest risk identified in the initial review.
70

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 So if the information that you’re 

2 submitting is not germane to the, you know, the 

3 plausible path of increased plant pest risk, 

4 admitting that information now only gives us more 

5 information that we need to then read through and 

6 look at but it slows the whole process down. 

7 APHIS will use publicly available

8 information and any additional information that

9 you submit when we conduct our PPRA.

10 And with that, I will, this concludes 

11 this presentation and welcome any questions you 

12 have.

13 And I will also welcome Bernadette and 

14 Subray Hegde to weigh in on questions that you 

15 may have as we undertake this as it sits, Subray’s

16 division, BRAP that would be conducting the 

17 regulatory status review.

18 So with that, I give it back to you, 

19 Doug.

20 MR. McKALIP: Yes, thank you. I 

21 really appreciate that presentation. And if 
71

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 folks want to press pound two to get in the queue 

2 for verbal questions.

3 In the meantime, Alan, we did have a 

4 couple questions that were submitted in writing. 

5 One, Audrey Leonard, asked, are re-review 

6 requests only available when a request has been 

7 denied due to PPR or is it possible to request a 

8 re-review of a plant that has been approved?

9 MR. PEARSON: If we have completed 

10 step two and gone through the FR process and found

11 at the end of that that the plant is unlikely to 

12 pose an increased plant pest risk, then 

13 therefore, would no longer be regulated under 

14 SECURE, the re-review could be requested after 

15 that. 

16 However, I want to emphasize that 

17 there would have to be scientifically valid 

18 evidence submitted in that request for re-review. 

19 And we are not stating here that a request for 

20 re-review would automatically trigger re-review. 

21 We would have to evaluate that request and decide 
72

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 then.

2 MR. McKALIP: Okay. Thanks, Alan. 

3 And regarding the RSR review, could you please 

4 expand on the applicable environmental findings? 

5 What sorts of characteristics in addition to 

6 weediness, et cetera might prompt an 

7 environmental review assuming that this is a 

8 formal NEPA review?

9 MR. PEARSON: So we would not, I want 

10 to clarify that the RSR process does not itself 

11 constitute an environmental review under the 

12 NEPA.

13 If we undertake a review under NEPA, 

14 that would be determined, you know, we would have 

15 to look at that at that time to determine whether 

16 such a review is needed.

17 But it wouldn’t be driven by our RSR 

18 request itself but rather by whether or not the 

19 decision is one that might trigger the NEPA re20 review process. That is an area that we’re still 

21 exploring. 
73

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 I don’t know, Bernadette, if you want 

2 to comment further on that.

3 MS. JUAREZ: I think that’s exactly 

4 accurate of where things are. Thanks.

5 MR. McKALIP: Okay. Thanks, Alan. 

6 We’ve got a question submitted in writing, can 

7 you elaborate on the purpose of the plant trait 

8 MOA table which was located on the BRS website.

9 MR. PEARSON: Sure the purpose of the 

10 plant trait MOA table is really to inform the 

11 regulated community of which plant trait MOAs 

12 would qualify for exemption.

13 The exemption listed in section 

14 340.1(c) of the SECURE rule, which is an 

15 exemption for a plant that has the same plant 

16 trait MOA as one that we had already determined 

17 either pursuant to our old petition process or 

18 pursuant to the new RSR process is unlikely to 

19 pose an increased plant pest risk and therefore

20 is not regulated.

21 That’s why once we complete an RSR 
74

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 process either at step one if we make that finding 

2 at the end of step one or at step two if we make 

3 it after completing step two if you are to add 

4 that plant trait MOA the PT MOA table.

5 MR. McKALIP: Thanks, Alan. Another 

6 question submitted in writing, what happens if

7 the APHIS review, a publicly available literature 

8 comes across any data not provided by the 

9 requestor that would indicate a potential risk?

10 MR. PEARSON: If we came across that 

11 data, we would evaluate that data and that would 

12 go into our risk assessment or risk analysis.

13 MR. McKALIP: Thanks, Alan. Operator, 

14 do we have any verbal questions in the queue 

15 currently?

16 OPERATOR: At this time, we have no 

17 one in the queue.

18 MR. McKALIP: Okay. Thank you, Alan. 

19 I don’t see any further questions in writing, so 

20 I really appreciate that presentation and your 

21 responses to the folks’ questions.
75

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 MR. PEARSON: Certainly, and I’ll just 

2 repeat again that we do hope to make this guidance 

3 publicly available in the future. And there will 

4 be opportunity for any of our stakeholders to 

5 comment on the guidance prior to us finalizing 

6 it.

7 So we will certainly be opportunities 

8 to, in the future, you can ask us additional 

9 questions or comments, suggestions and so on. We 

10 welcome any suggestions so we can make the 

11 guidance, you know, as useful and clear for our 

12 stakeholder community as possible.

13 MR. McKALIP: Terrific. Thanks, Alan. 

14 Yes, that’s a good reminder the stakeholder 

15 meeting is just one of any day that folks can 

16 approach us and request additional clarification 

17 and additional information. So we’re always here 

18 to help folks. Thanks, Alan.

19 MR. PEARSON: Sure.

20 MR. McKALIP: Okay. That moves us to 

21 our next and final agenda item, which is Doug 
76

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Grant to provide a regulatory operations update.

2 Doug is one of the new names, at least 

3 new in his new position, but certainly a veteran 

4 of BRS, who was provided in the first slide deck 

5 of our meeting today.

6 Doug is the director of the BRS 

7 Regulatory Operations Program, and he formerly

8 served as the Chief of the Western Compliance 

9 Assurance Branch, which is located in Fort 

10 Collins, Colorado. And he was in that position 

11 from 2011 until June of this year. 

12 Doug holds a master’s degree and Ph.D. 

13 in plant ecology from Colorado State University. 

14 He grew up in Ohio and then moved to Colorado to 

15 go to college. 

16 Doug joined APHIS in 2005 after 

17 working for the USDA ARS at the Crop Research 

18 Laboratory from 1999 to 2005.

19 Prior to working for USDA, Doug held 

20 several positions in Colorado State University as 

21 well as the Colorado Department of Natural 
77

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Resources and the Colorado Natural Heritage 

2 Program.

3 So, Doug, I’ll turn it over to you for 

4 your portion of the presentation.

5 DR. GRANT: Great. Good afternoon, 

6 everyone. Thanks, Doug, for the introduction, 

7 and thanks to everyone for joining us today.

8 We’re changing gears here to talk a 

9 little bit about some of our compliance 

10 activities, and then, I will also be giving some 

11 eFile updates for folks.

12 First, I want to share some 

13 information about how BRS chooses which trials to 

14 inspect.

15 So we gathered the post planting 

16 report data, known as PPRs or sometimes we just 

17 call them planting reports, and we use that data 

18 to select which site will be inspected.

19 Most of our inspections are for field 

20 trials or releases into the environment. But 

21 some are also for destination facilities that 
78

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 BRAP identifies and for those they may be 

2 inspected prior to final permit issuance.

3 For the field trials, we use the 

4 information that we get from the post planting 

5 reports. And those data are compiled into a 

6 database.

7 And then, we also map them using 

8 geographic information systems based on the GPS 

9 coordinates provided in the planting reports. 

10 And we take compliance history into account as 

11 well.

12 So we basically select the sites for 

13 inspection to make sure that we’re inspecting 

14 them at an appropriate time. And our inspection 

15 selection is based on risk where lower risk 

16 trials with lower risk species are selected for

17 inspection at a lower frequency.

18 We’ve made a big shift this year to 

19 doing virtual inspections during the COVID-19 

20 pandemic. 

21 And we actually piloted these virtual 
79

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 inspections a couple of years ago in FY ‘18, and 

2 we refer to them often as monitoring and

3 evaluation interviews, or MEIs.

4 So once we entered into the travel 

5 restrictions associated with the pandemic, we 

6 made the shift to doing all of our inspections 

7 with this virtual process beginning in March of 

8 2020.

9 And just to tell you a little bit 

10 about how that process works, the inspector 

11 schedules the interview with the responsible 

12 person for the given authorization we are 

13 inspecting and requests records such as volunteer 

14 monitoring, or equipment cleaning records, a map 

15 or diagram of the site, the GPS coordinates and 

16 at least one current photo.

17 And then, the BRS inspector evaluates 

18 the submitted record, checks the compliance 

19 history of the regulated MV and then compares the 

20 map and the GPS coordinates that we’ve been given 

21 with the information on the authorization and the 
80

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 information submitted on the planting reports.

2 So we’ve found that we’ve had really 

3 good success with the virtual inspections as a 

4 way to provide meaningful virtual oversight of 

5 regulated activities.

6 We incorporated using video 

7 conferencing technology when possible to help 

8 with our visualization of what’s going on at a 

9 site. And we also have started using remote 

10 sensing technology to help assist us with looking 

11 at trial sites from afar.

12 Just to highlight a couple of the 

13 projects, we really focused on over the last year 

14 and in the last two years really, this portal 

15 project has been a really big one.

16 We have this APHIS GIS portal that is 

17 used by all different programs within the APHIS 

18 to analyze geospatial data. And, you know, that 

19 depends on getting accurate GPS coordinates, 

20 obviously, for where these trials are located.

21 And if cloud-based data secure portal 
81

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 for use and it’s a FedRAMP authorized system, 

2 then the portal really allows us to share 

3 information with BRAP, between BRAP and ROP for 

4 some of the analysis they do prior to issuing a 

5 permit.

6 And then, we look at the relevant data 

7 layers, and we actually can pair some of the GIS 

8 work with some of the remote sensing work that 

9 we’ve been doing.

10 So we use the remote sensing to find 

11 information, and this is primarily satellite 

12 imagery. And it can be used to look for the 

13 relevant dates of when the trial occurred.

14 So we can use this imagery to help 

15 verify isolation distance. It can be used to 

16 help verify planting and harvest dates for a 

17 trial site. And essentially to support or refute 

18 observations that are made during the virtual 

19 inspections.

20 So in terms of what we did this year, 

21 this fiscal year that we just wrapped up, we had 
82

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 pretty high compliance rates, as we do most 

2 years. They were a little bit lower, 95 percent 

3 in FY ‘20 compared to 97 percent FY ‘19.

4 For the inspection outcomes, we have

5 80 percent of the inspections were noted as 

6 compliant in the closeout letters for those 

7 locations.

8 We had 5 percent that were deemed to 

9 be non-compliant with regulatory requirements. 

10 And those consist of notices of non-compliance.

11 We have another category as well which 

12 is, we sometimes share information about issues 

13 that were identified by the inspector, but the 

14 trial is still compliant.

15 So essentially, conveying concerns 

16 about issues that could lead to compliance issues 

17 down the road. And those are in a couple of 

18 different categories; notice of compliance with 

19 comments or with notices of findings.

20 And we also have in our compliance 

21 evaluation and enforcement branch, they handle a 
83

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 lot of self-reports that come into our compliance 

2 inbox and to our compliance hotline.

3 Those self-reports deal with things 

4 such as losses of confinement related due to 

5 severe weather-related events.

6 We did notice the number of compliance 

7 challenges in FY ‘20, and I sort of have the most 

8 common types of challenges we encountered listed 

9 here. There were 12 instances where we had a 

10 release in an area or quantities not authorized. 

11 We had 19 instances of failure to comply with 

12 Supplemental Permit Conditions. We had 28 

13 instances of late or missing Post-Planting 

14 Reports. We had 21 instances of late or missing 

15 Field Test Reports.

16 And I think, you know, we noticed a 

17 definite trend that a lot of these challenges 

18 were associated with the pandemic and people not 

19 having access to the location where their 

20 information or records might be stored.

21 Or they may have accidently shipped 
84

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 the material to the wrong location or even 

2 planted it in the wrong location.

3 And when those happen, we worked to 

4 quickly bring those locations back into 

5 compliance.

6 So taking a look at where we had 

7 plantings across the U.S. in the past year, we 

8 had over 3,000 planting locations authorized.

9 In terms of what was actually planted 

10 in FY ‘20, we had 1,027 sites that were planted 

11 or active.

12 And then, when you look at the map, 

13 you can see some areas of higher concentration 

14 such as in Iowa and Illinois here in the Midwest, 

15 you know, down in the Southeast along the coastal 

16 areas.

17 And we have, you know, quite a 

18 constant amount of activity in our winter nursery 

19 locations in Hawaii and Puerto Rico.

20 In terms of inspections conducted, in 

21 FY ‘20, there were a total of 554. And that 
85

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 equates to roughly half of the sites that are 

2 planted. These inspections consist of inspecting 

3 annual as well as perennial crop.

4 The majority of the inspections are 

5 conducted in season which means during the years 

6 that the trial is planted. But some are also 

7 conducted post-harvest and the year after the 

8 trial.

9 And we also have some plant-made 

10 pharmaceutical or industrial trials or PMPIs. 

11 And those get inspected multiple times during the 

12 year of the trial as well as the year following 

13 the trial.

14 Now I’m going to move into just 

15 sharing a little bit about the distribution of 

16 work for who is conducting the inspection.

17 I use this graph to highlight how 

18 going back to 2014 -- this just shows even years 

19 -- but we’ve really increased the percentage of 

20 inspections that are conducted by BRS personnel.

21 And so, we’ve got a decrease in the 
86

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 number of inspections that are conducted by our 

2 sister program APHIS Plant Protection and 

3 Quarantine or PPQ.

4 And this year we also saw a decrease 

5 in the number of inspections done by our state 

6 partners who conduct inspections on behalf of 

7 APHIS in a number of locations.

8 And this was primarily related to the 

9 shift that we made to conducting all our 

10 inspections virtually. And we have trained up a 

11 number of PPQ inspectors to do the virtual 

12 inspections at this point.

13 So you’ll, you know, you could be 

14 contacted by someone from BRS or someone from PPQ 

15 or from the state’s department of agriculture 

16 depending on which state you live in to arrange 

17 time for an inspection.

18 Looking at the numbers broken down by 

19 quarter, you can see we had 69 inspections in Q1, 

20 89 in Q2, 69 in Q3, and then 317 in Q4.

21 And that sort of log jam or big chunk 
87

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 of work generally happens in that most of the 

2 trials in continental U.S. aren’t planted until 

3 Q3 of the fiscal year. And then, we have a little 

4 bit of lag time before we get those planting 

5 reports and get the inspections scheduled.

6 So we definitely have an extremely 

7 high inspection workload in Q4, and that is 

8 typical for us.

9 All right moving on to eFile update 

10 and the ePermits transition.

11 So since go-live we’ve had 48 

12 applicants working in the pilot for the APHIS 

13 eFile system. Eighty-two applications have been 

14 submitted for BRS authorization. So far, a 

15 number of those have come in quite recently.

16 Fifty-nine authorizations have been 

17 processed so far. And we’ve actually done 

18 inspections on some of these as the folks in the 

19 Regulatory Operations Programs learn the 

20 workflows in the APHIS eFile system.

21 And we’ve made some really good 
88

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 progress with the eFile system. There’s improved 

2 user registration and continued development. And 

3 that development is heading in the right 

4 direction.

5 In terms of the transition dates that 

6 folks want to make sure to be aware of to APHIS 

7 eFile, the transition from ePermits to eFile 

8 really begins in earnest with -- April 1 of 2020 

9 was the last day to submit notification in APHIS 

10 eFile.

11 And I believe that these slides should 

12 say April 1 of 2021 for the last day to submit 

13 notifications in APHIS eFile.

14 The April 4th of 2021 is the last day 

15 to submit any permits or notification 

16 applications in ePermits. And these are 

17 obviously, related to the transition to the new 

18 SECURE rule.

19 And then, April 5th of 2021 will be 

20 when applicants must use eFile. We will only be 

21 accepting applications for permits at that time, 
89

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 and APHIS applicants will also be able to use the 

2 eFile system to request confirmation of an 

3 exemption from regulation. 

4 So in the transition that we have 

5 going to eFile, we have providing supported user 

6 guides, and we are also going to be offering 

7 training available to applicants.

8 So the user guides will be available 

9 to assist you in the transition as seamlessly as 

10 possible from ePermits to eFile. And the 

11 instructor-led training opportunities for 

12 applicants are sort of being planned around those 

13 final transition dates in early April of next 

14 year.

15 If you are interested in doing some of 

16 this training, there is a email that we’ll 

17 provide on the last slide in terms of how to 

18 contact the help desk when you need assistance.

19 And you can also see our BRS website 

20 here and get signed up for that stakeholder 

21 registry. There’s a link to that on the left-
90

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 hand side of our BRS website.

2 So if you get signed up for that 

3 registry, then you’ll be able to stay informed 

4 about when these instructor-led and other 

5 training resources are available to you.

6 So in terms of the future availability 

7 of ePermits, it’s going to sunset at some point 

8 in time.

9 But for applications that are 

10 submitted in ePermits, they will complete their 

11 entire lifecycle in ePermit. There is no way for 

12 us to move the information from an application or 

13 an authorization in ePermits to eFile.

14 So if it starts in the ePermit system, 

15 it will finish its lifecycle in the ePermit 

16 system.

17 So likewise, if you’re submitting 

18 reports or notices that are necessary for a 

19 compliance of an authorization, those for 

20 authorizations issued through ePermits should 

21 also be submitted in ePermits.
91

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 And for the foreseeable future, 

2 there’s really not going to be any restriction to 

3 ePermits read access.

4 And we don’t really have a timeline 

5 set just yet for the date that ePermits will no 

6 longer be functioning because it depends on a lot 

7 of other APHIS programs but we will definitely be 

8 keeping stakeholders informed.

9 And just a reminder, like I said, 

10 there won’t be any data migration from ePermits 

11 to APHIS eFile. 

12 APHIS eFile early adoption. You know, 

13 we want to encourage applicants to make the 

14 transition early. Don’t wait until April.

15 There some nice features that we have 

16 in eFile that have been turned off or not in place 

17 in ePermits, such as submitting multiyear ePermit 

18 applications.

19 You can get familiar with the system. 

20 You can use the previously submitted construct 

21 feature to easily add constructs from previous 
92

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 eFile applications.

2 And you can also set up sharing 

3 accounts. And those will allow your teams to 

4 collaborate within your organization on 

5 applications.

6 But the first step is really to get 

7 registered with your e-authorization account via 

8 the APHIS eFile webpage. And that address is 

9 right here.

10 So once you get your registration, 

11 your e-authentication account registered, you’ll 

12 be able to work on submitting your first 

13 application.

14 So I hope this information has been 

15 helpful for you today. We’re here to assist you 

16 through this transition to the new APHIS eFile 

17 system.

18 And we have a really great team that’s 

19 happy to help you.

20 If you have questions, comments, or 

21 concerns, or just need help with the transition 
93

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 to the new system, please contact the team at 

2 this email address, 

3 efile.communications@usda.gov, and they’ll be 

4 happy to help you.

5 I want to thank Miranda Wanex, Megan 

6 Dexter, and Heather Brown for help with the 

7 slides, and thank you all for your attention.

8 With that, I will be happy to take 

9 some questions.

10 MR. McKALIP: Great. Thanks, Doug. 

11 We did have a question submitted in writing 

12 asking has the new virtual inspection shift 

13 proven to be successful, and do you see this being 

14 a mainstay for your program?

15 DR. GRANT: Yes. Thank you, Doug, for 

16 the question. You know, we’ve found it to be 

17 quite successful.

18 We have a little bit more lead time 

19 involved in terms of preparing for a virtual 

20 inspection than we do for an in-person 

21 inspection.
94

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 And we’ve really felt like we’ve been 

2 able to provide good virtual oversight using our 

3 technology and the tools that we have, such as 

4 video conferencing.

5 So we will continue to use it to 

6 supplement our regular in-person inspection work 

7 as we go into the new year.

8 I don’t think we anticipate doing a 

9 lot of in-person inspection work early in the new 

10 year. But, hopefully, by the time the growing 

11 season rolls around, you know, we’ll have travel 

12 restrictions lifted. And the pandemic will be 

13 subsiding to the degree that we can get out and 

14 safely do in-person inspections.

15 I think that there’s a lot of value to 

16 both, so we’ll probably have a little bit more of 

17 a hybrid model as we move through the future.

18 MR. McKALIP: Terrific. Thanks for 

19 that response. I would remind participants that 

20 pound two is the way to get into the queue for 

21 asking a verbal question over the phone.
95

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 And I know we’ve got just a little 

2 over ten minutes left that we had allotted for 

3 this meeting.

4 And, Doug, one of our participants 

5 commented in the chat box that they have an 

6 inspection coming up today at 3:00 p.m., so we 

7 certainly want to keep everybody on schedule here 

8 so that they can get to their meeting.

9 DR. GRANT: Right.

10 MR. McKALIP: -- take care of their 

11 needs.

12 DR. GRANT: Yes.

13 Event producer, do we have any calls 

14 currently in queue verbally?

15 OPERATOR: We currently do not have 

16 anybody in the queue.

17 MR. McKALIP: Okay. We’ll give it 

18 just a couple moments here if folks do have 

19 either written question or verbal one to give 

20 them a last chance to ask.

21 Okay, Doug, we did have a question 
96

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 submitted in the chat box. The individual asked 

2 -- and if they missed this, they apologize -- but 

3 wanted to know if it’s possible to see a list of 

4 plantings of new material, if not by name, by 

5 crop?

6 DR. GRANT: I’m not quite sure that I 

7 understand the question. 

8 So they’re asking for how many of the 

9 plantings that we had to be broken down by crop 

10 species?

11 MR. McKALIP: That’s how I read the 

12 question. Is there some additional detail on 

13 what’s being planted?

14 DR. GRANT: You know, I think we might 

15 be able to provide some information like that. I 

16 certainly don’t have it at my fingertips. And we 

17 would need to, you know, make sure that we were 

18 protecting any confidential business 

19 information.

20 So I would suggest that that person 

21 send their question to the BRS inquiry -- I’m 
97

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 forgetting the name of the email address, Doug, 

2 maybe you can share that -- and they can submit 

3 it and then we can take a look.

4 MR. McKALIP: You bet. Yes. We can 

5 look that up in the chat box. I think their 

6 question, Doug, was precipitated by the slide 

7 that had the 2020 unique planting’s, the one 

8 thousand twenty-seven unique planting’s. 

9 So this participant was interested in 

10 more detail about the planting’s.

11 Doug, you made a really super 

12 important point about CBI there. But yes, we can 

13 further, you know, follow-up with them about that 

14 question.

15 DR. GRANT: Yes. The BiotechQuery

16 email address would probably be the best place 

17 for that question, Doug.

18 And I can tell you that if, you know, 

19 a lot of corn, you know, a lot of soy beans, a 

20 good amount of cotton, and a whole bunch of other 

21 species, you know, almost anything you can think 
98

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 of under the sun.

2 So, yes, we can work on a list like 

3 that. And it varies a little bit from year to 

4 year, but corn is definitely king in terms of 

5 taking up the most time for our inspection 

6 activities.

7 MR. McKALIP: Okay. Doug, an 

8 additional question in writing about the training

9 to industry for the new eFile process.

10 And I think folks are just sort of, if 

11 they’re not familiar with what we’ve done 

12 already, just hearing a little bit more about 

13 what even may be planned further in terms of 

14 training stakeholders and how to utilize the 

15 eFile system.

16 DR. GRANT: So we’ll be holding 

17 webinars, and we’ve held those in the past, too, 

18 with some of the initial pilot participants for 

19 the APHIS eFile system.

20 And those dates for those webinars 

21 will be posted on the BRS webpage.
99

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 I’m not sure exactly how many of those 

2 opportunities there will be, but I do know that 

3 they will be recorded, and the recordings will 

4 also be available via the BRS website.

5 MR. McKALIP: Good. Thanks, Doug. 

6 Just a reminder, you did cover this.

7 But if folks are not currently 

8 registered on the BRS stakeholder registry, 

9 that’s a great way that will help, you know, 

10 rather than checking the website, to get 

11 information.

12 It is pushed from us to all of you. 

13 So if you’re not registered, that’s a great way 

14 to keep current on those kinds of opportunities 

15 as they are scheduled.

16 We got a question about will the 

17 recording of this presentation be posted or 

18 emailed?

19 So again, the entire slide deck is 

20 available on our website. We also have a 

21 transcription service that will take the entire 
100

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 meeting and will make a transcript available of 

2 this session.

3 Event producer, do we have any calls, 

4 questions verbally in the queue currently?

5 OPERATOR: At this time, you have no 

6 one in the queue.

7 MR. McKALIP: We’ll wait just a moment 

8 more, Doug, to see if anyone submits one in 

9 writing.

10 Okay, hearing none, Doug, thank you so 

11 much for that very comprehensive overview of the 

12 regeat operation.

13 DR. GRANT: Thank you.

14 MR. McKALIP: Okay. That was the 

15 agenda for today, and we really appreciate all 

16 the very thoughtful questions and really 

17 excellent comments that were provided throughout 

18 the session.

19 And as I think we covered a few times, 

20 the stakeholder meeting isn’t the only chance to 

21 connect by any stretch.
101

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 So we’ve provided a lot of resources 

2 here to go along with this meeting and a lot of 

3 different ways for you to connect with us. And 

4 we would encourage you, at any time, to ask 

5 questions and keep clarity because that certainly 

6 is helpful to us as much as it is to you too.

7 Along those lines, we’ll be looking 

8 for feedback on the format of this session.

9 You know, this is a very special year, 

10 and we’re all trying to feel our way through it. 

11 And we hope that this has been a really good way 

12 to conduct the stakeholder meeting, but we 

13 certainly welcome your thoughts and ideas on how 

14 we can best share with you.

15 So with that, Bernadette, do you have 

16 any closing comments that you’d like to make 

17 before we wrap up and close the phone line?

18 MS. JUAREZ: I just really appreciate 

19 everybody who connected with us today.

20 And like you said, Doug, we hope you 

21 found this information and format helpful.
102

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 In some instances, it may have been 

2 very information dense, and we recognized that 

3 you may need some time to think about other 

4 questions you might have and come back to us.

5 And we look forward to connecting with 

6 you if you have further questions on some of the 

7 topics that we talked about today and in the 

8 future.

9 MR. McKALIP: Great. Thanks so much, 

10 Bernadette. Yes. Thank you. With that, Event 

11 Operator will close out the lines. 

12 And for all the stakeholders on the 

13 call, we sure look forward to connecting with you 

14 real soon in the future.

15 And thanks for all you do.

16 (Whereupon, the above-entitled matter 

17 went off the record at 2:57 p.m.)

18

19